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Clinical trialNCT00442156CompletedObservational

The Course of Response to Focal Photocoagulation for DME

SponsorJaeb Center for Health ResearchEnrollment122Diabetic Macular EdemaDiabetic Retinopathy
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The study objective is to determine the course of changes in OCT measured macular thickness and visual acuity following a single session of focal photocoagulation for center-involved DME. The response will be evaluated separately in eyes with and without prior focal photocoagulation for DME. The purpose is to determine the proportion of eyes that continue to improve at least 5 letters in visual acuity or at least 10% in central retinal thickness after a session of focal photocoagulation. In addition, the study will explore whether any baseline factors can be identified that are predictive of the response. All subjects will have follow-up visits 8 weeks and 16 weeks post treatment. At the 16-week visit, study eyes are evaluated for change in retinal thickness and visual acuity from baseline. * Treatment is to be deferred and follow up continued if visual acuity letter score has improved by \>5 or OCT central subfield thickness has decreased by \>10% compared with baseline. * If visual acuity letter score has not improved by at least 5 and OCT central subfield thickness has not decreased by at least 10%, then the eye is classified as 'not improved' and the investigator may provide additional treatment. Follow up ends for eyes that receive additional treatment at this visit. However, if the investigator and participant elect to defer additional treatment (even if deferral criteria are not met), then follow up will continue until the study eye receives additional treatment for DME. * Eyes continuing in follow up have visits every 8 weeks (+1week) as long as there has been continued improvement in visual acuity (letter score improved \>5 ) or retinal thickness (central subfield thickness decreased by \>10%) compared with the visit 16 weeks earlier. The longest follow-up time will be 48 weeks. By providing information on the length of time during which clinically meaningful improvement occurs following focal photocoagulation, clinicians will be better able to determine when further photocoagulation or other treatments should be considered for persistent DME. Depending on the results of this study, a future randomized clinical trial will be considered comparing the more aggressive retreatment photocoagulation regimen currently serving as the standard DRCR Network approach to focal photocoagulation for macular edema with the less aggressive regimen evaluated in this protocol.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

32 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Southern California Desert Retina Consultants, Mc

    Palm Springs, California, United States

  • Retina Vitreous Consultants

    Fort Lauderdale, Florida, United States

  • Retina Consultants of Southwest Florida

    Fort Myers, Florida, United States

  • Central Florida Retina Institute

    Lakeland, Florida, United States

  • Southeast Retina Center, P.C.

    Augusta, Georgia, United States

  • Retina Associates of Hawaii, Inc.

    Honolulu, Hawaii, United States

  • Raj K. Maturi, M.D., P.C.

    Indianapolis, Indiana, United States

  • American Eye Institute

    New Albany, Indiana, United States

  • Retina and Vitreous Associates of Kentucky

    Lexington, Kentucky, United States

  • Paducah Retinal Center

    Paducah, Kentucky, United States

  • Maine Vitreoretinal Consultants

    Bangor, Maine, United States

  • Elman Retina Group, P.A.

    Baltimore, Maryland, United States

  • Southern New England Retina Associates

    Attleboro, Massachusetts, United States

  • Joslin Diabetes Center

    Boston, Massachusetts, United States

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, United States

  • Vitreo-Retinal Associates

    Grand Rapids, Michigan, United States

  • Associated Retina Consultants

    Williamsburg, Michigan, United States

  • Delaware Valley Retina Associates

    Lawrenceville, New Jersey, United States

  • University of Rochester

    Rochester, New York, United States

  • Retina-Vitreous Surgeons of Central New York, Pc

    Syracuse, New York, United States

  • University of North Carolina, Dept. of Ophthalmology

    Chapel Hill, North Carolina, United States

  • Charlotte Eye, Ear, Nose and Throat Assoc., Pa

    Charlotte, North Carolina, United States

  • Retina Associates of Cleveland, Inc.

    Beachwood, Ohio, United States

  • Casey Eye Institute

    Portland, Oregon, United States

  • Carolina Retina Center

    Columbia, South Carolina, United States

  • Palmetto Retina Center

    Columbia, South Carolina, United States

  • Retina Research Center

    Austin, Texas, United States

  • Texas Retina Associates

    Dallas, Texas, United States

  • Charles A. Garcia, Pa & Associates

    Houston, Texas, United States

  • Retina and Vitreous of Texas

    Houston, Texas, United States

  • Texas Retina Associates

    Lubbock, Texas, United States

  • University of Wisconsin-Madison, Dept. of Ophthalmology

    Madison, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jan 2007
Primary completion
30 Jun 2008
Completion
30 Jun 2008
Last update posted
26 Aug 2016
Registered enrollment
122
Registry id
NCT00442156

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.